Leukemia, B-Cell
Conditions
Keywords
Chimeric Antigen Receptor-Modified T Cells, CART, Recurrent B Cell Acute Lymphoblastic Leukemia, refractory B Cell Acute Lymphoblastic Leukemia, ALL
Brief summary
This study aims to evaluate the safety and clinical activity of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in treating patients with recurrent or refractory CD19 positive B cell ccute lymphoblastic leukemia,and dynamically observe the changes of CAR-T in patients and the residual tumor.
Detailed description
In this single-center, open-label, single-arm, prospective clinical trial, a total of 20 recurrent or refractory CD19+ B cell acute lymphoblastic leukemia patients will be enrolled.After recruiting eligible patients,autologous peripheral blood mononuclear cells(PBMCs) will be purified from whole blood.The CD3+ T cells were subsequently selected and re-stimulated by anti-CD3 and anti-CD28 monoclonal antibodies.T cells will be transduced with lentiviral vector for the generation of the CD19 CART cell and administered by i.v. injection.The purpose of current study is to determine the safety and clinical efficacy of CD19 CAR T cells therapy in patients with recurrent or refractory CD19+ ALL.
Interventions
BIOLOGICALCD19-targeted CART cells
CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv.This is a second generation CRAT.
Sponsors
jiuwei cui
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with recurrent or refractory CD19+ ALL receive CD19 CAR T-cell immunotherapy.
Eligibility
Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Recurrent or refractory B cell derived acute lymphoblastic leukemia (ALL) * Patients who have failed at least one line of a standard treatment without effective treatment measures at present * CD19 expression on the surface of B-ALL cells must be detected * KPS\>80 * Life expectancy \>3 months * Patients must have adequate cardiac function (no electrocardiogram with obvious abnormality, LVEF≥50%),adequate pulmonary function as indicated by room air oxygen saturation of \> 90%, and adequate renal function (Cr≤2.5 times of the normal range) * The alanine aminotransferase (ALT) and the aspartate aminotransferase (AST)≤ 3 times of the normal range, and the total bilirubin (TBIL)≤2.0mg/dl(34.2umol/L) * Hemoglobin(Hgb)≥80g/L * Without contraindication of apheresis and cell isolation * Patients and their families volunteer to participate in the research with signed written informed consent
Exclusion criteria
.Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease; another severe and/or life-threatening medical disease. * Evidence of uncontrolled current serious active infection * HIV/HBV/HCV infection * Pregnancy and nursing females * Systemic glucocorticoid therapy within one week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate(ORR) | Participants will be followed for the duration of the treatment, with an expected average of 3 months. | ORR is defined as the proportion of partial responses plus complete responses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival(PFS) | 15 years | Progression-free survival is defined as the time from enrollment to first observation of progression or date of death (from any cause). |
| Overall survival(OS) | 15 years | Overall survival, defined as the time from enrollment until death due to any cause. For patients who do not die, time to death will be censored at the time of last contact. |
Outcome results
None listed